Cognitive Behavioral Therapy for Chronic Pain in Adults With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Cognitive Behavioral Therapy for Chronic Pain in Adults With Cerebral Palsy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06269926
• Other study ID #: IRB00431182
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: April 2025

Study information

• Verified date: February 2024
• Source: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Contact: Paul Salib, B.S
• Phone: (443) 923-9272
• Email: salib[@]kennedykrieger.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to understand if cognitive behavioral therapy can improve pain-related thought patterns and pain-related impairment in adults with cerebral palsy.

Description:

The majority of adults with cerebral palsy have chronic pain. The investigators have found that communicative adults with cerebral palsy reporting the most pain-related impairment had clinically-elevated catastrophizing thought-patterns. Because of this, a treatment targeting pain-related catastrophizing thought patterns may help reduce pain-related impairment. One potential treatment is cognitive behavioral therapy for chronic pain (CBT-CP).

To investigate the efficacy of CBT-CP on reducing pain-related impairment and catastrophizing thought patterns in communicative adults with cerebral palsy, investigators will conduct and compare evaluations before and after participants receive a combination of CBT-CP and pain education. CBT-CP involves weekly group-therapy sessions for 12 weeks. Pain education is comprised of 12 weeks of usual medical care in addition to being given an educational booklet on chronic pain.

Participants will be randomly assigned to receive either pain education followed by CBT-CP (group 1; Education-CBT), or the reverse order (group 2; CBT-Education). Participants in both groups will be assessed at the beginning of the study (at baseline; prior to group assignment), and then once every 3 months during the 12-month duration of the study. After baseline, assessments two and three will occur immediately after the 12 week pain education/CBT intervention periods (3 and 6 months into study), while assessments four and five are follow-up questionnaires to assess post-treatment effects (9 and 12 months into study).

This study will be conducted at the Kennedy Krieger Institute in Baltimore, Maryland, USA. 40 participants who meet all inclusion/exclusion criteria will be recruited. Participants must endorse the ability and willingness to participate in all assessment and group sessions regardless of randomization outcome.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. At least 18 years of age

2. Diagnosis of cerebral palsy

3. Reports that pain at least "somewhat" interfered with at least one aspect of life in the past 7 days

4. Clinically elevated Pain Catastrophizing Scale (PCS) score

5. Endorses the ability and willingness to participate in all assessment and group sessions regardless of randomization outcome

6. Shows developmental readiness to benefit from CBT via the Behavior, Thought, Feeling Questionnaire (BTFQ)

Exclusion Criteria: (if met then participant will not eligible to participate)

1. Previously received Cognitive Behavioral Therapy (CBT) for chronic pain

Related Conditions & MeSH terms

• Brain Diseases
• Catastrophizing Pain
• Central Nervous System Diseases
• Cerebral Palsy
• Chronic Pain
• Coping Behavior
• Nervous System Diseases
• Pain Catastrophizing
• Pain, Chronic

Intervention

Behavioral:
• Cognitive Behavioral Therapy for Chronic Pain
Treatment for chronic pain that addresses the relationship between thoughts, feelings and behaviors.

Other:
• Pain education
A booklet on chronic pain (in this study, an educational pamphlet from the Oregon state health department) that provides pain education in addition to usual medical care.

Locations

Country	Name	City	State
United States	Kennedy Krieger Institute	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.	Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Catastrophizing	The Pain Catastrophizing Scale (PCS) is a 13-item questionnaire that directly assesses catastrophic thought patterns in regards to painful past experiences. Responses are recorded 5-point scale, with 0 being "not at all" and 4 being "all the time"; higher scores represent worse outcomes.	Will be assessed at baseline (prior to randomization) as well as every 3 months throughout the 12 month study timeframe for each cohort
Secondary	Global Impressions of Change	single-item 7-point scale ranging from chronic pain being "very much improved" to "very much worse"; higher scores represent better outcomes.	Will be assessed at baseline (prior to randomization) as well as every 3 months throughout the 12 month study timeframe for each cohort
Secondary	Pain Interference	8-item PROMIS Pain Interference Short Form 8a for reporting the level in which pain interfered with aspects of life in the last 7 days. Responses are recorded 5-point scale, with 1 being "not at all" and 5 being "very much"; higher scores represent worse outcomes.	Will be assessed at baseline (prior to randomization) as well as every 3 months throughout the 12 month study timeframe for each cohort
Secondary	Pain Intensity	3-item PROMIS Pain Intensity Short Form 3a for reporting the level that an individual hurts in the last 7 days. Responses are recorded 5-point scale, with 1 being "had no pain" and 5 being "very severe"; higher scores represent worse outcomes.	Will be assessed at baseline (prior to randomization) as well as every 3 months throughout the 12 month study timeframe for each cohort
Secondary	Anxiety/Mood symptoms	4-item questionnaire to assess the presence of symptoms of anxiety and depression in the last 14 days. Responses are recorded 4-point scale, with 0 being "not at all" and 4 being "nearly every day"; higher scores represent worse outcomes.	Will be assessed at baseline (prior to randomization) as well as every 3 months throughout the 12 month study timeframe for each cohort